Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures
Reported: October 24, 2018 Initiated: August 8, 2018 #Z-0162-2019
Product Description
Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures
Reason for Recall
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 20
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Chile, Netherlands.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures. Recalled by Zimmer Biomet, Inc.. Units affected: 20.
Why was this product recalled? ▼
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 24, 2018. Severity: Moderate. Recall number: Z-0162-2019.
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